E-alcohol Therapy - an Evaluation of Alcohol Therapy Delivered Via Video Conference

The study evaluates whether the introduction of e-alcohol therapy (alcohol therapy delivered via video conference) can break with some of the barriers related to alcohol treatment and thereby appeal to people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8). The study aims to evaluate the effect of e-alcohol therapy on initiation, treatment compliance and alcohol intake as compared to treatment as usual .

Study Overview

• Status: Completed
• Conditions: Problematic Alcohol Use
• Intervention / Treatment: Behavioral: E-alcohol therapy

Detailed Description

Background: Only a small proportion of those who have a problematic alcohol use receive treatment and compliance is low among the few that undergo treatment. If treatment more easily can be combined with everyday life and break with some of the barriers related to stigma by having a broader appeal, more people with a problematic alcohol use may seek and complete treatment. Alcohol therapy conducted via video conference may be an attractive treatment option and effective in reducing alcohol intake among people with a problematic alcohol use who do not seek traditional treatment.

Objective: The aim of this trial is to evaluate whether people with a problematic alcohol use (Alcohol Use Disorder Test score ≥ 8), who enroll in alcohol therapy delivered via video conference to a greater extent initiate as well as comply with treatment and reduce their alcohol intake compared to people allocated to standard alcohol treatment.

Design: Randomized controlled trial

Participants: 375 Danish citizens above 18 years with a problematic alcohol use (Alcohol Use Disorder Test (AUDIT) score >8).

Intervention: Participants are randomized to one of two groups:

1. Conversational therapy via video conference where participants are contacted by an alcohol therapist for the purpose of initiating a course of treatment where participants are not required to show up at a clinic.
2. Treatment as usual where participants receive contact information on their local alcohol treatment facility for the purpose of contacting the facility to initiate a face-to-face course of treatment at the clinic.

The allocation of participants to the intervention will be 1:1 to the intervention and the control group.

Methods: Data will be collected by questionnaire at baseline, 3 months and 12 months post randomization. Analyses will be intention to treat. Subgroup analysis will be conducted in relation to personal and demographic characteristics.

Process evaluation will be performed using a combination of questionnaires and qualitative interviews with participants, therapists and management at the clinics.

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1455
    • National Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Problematic alcohol consumption (Alcohol Use Disorder Test score ≥ 8)

Exclusion Criteria:

• Not legally able and willing to provide informed consent
• No provision of a functional e-mail address
• No provision of municipality of residence and phone number
• No access to a personal computer equipped with functional camera, audio equipment, and Internet access.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Conversational therapy via video conference where participants are contacted by an alcohol therapist for the purpose of initiating a course of therapy where participants are not required to show up at a clinic.	Behavioral: E-alcohol therapy; Conversational therapy sessions provided via video conference by a professional alcohol therapist.; Other Names: Electronic alcohol therapy
No Intervention: Control; Treatment as usual where participants receive contact information on their local alcohol treatment facility for the purpose of contacting the facility to initiate a face-to-face course of treatment at the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of treatment (completion of one session)	25% higher completion of one treatment session	3 months post randomization
Initiation of treatment (completion of one session)	25% higher completion of at least one treatment sessions	12 months post randomization
Compliance (completion of at least 3 sessions)	25% higher completion of at least three treatment sessions	3 months post randomization
Compliance (completion of at least 3 sessions)	25% higher completion of at least three treatment sessions	12 months post randomization
Total weekly alcohol intake (measured by Timeline follow back)	Higher reduction in total weekly alcohol intake (measured by Timeline follow back) (5 units)	3 months post randomization
Total weekly alcohol intake (measured by Timeline follow back)	Higher reduction in total weekly alcohol intake (measured by Timeline follow back) (5 units)	12 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly alcohol intake below national guidelines	20% increase in participants reporting a weekly alcohol intake below the national high risk drinking limits.	3 and 12 months post randomization
Weekly number of heavy drinking days	Lower number of weekly heavy drinking days (5+ units in one occasion)	3 and 12 months post randomization
Weekly drinking days	Lower number of weekly drinking days	3 and 12 months post randomization
Problematic drinking	Lower Alcohol Use Disorder Test score	12 months post randomization
Quality of life	Higher quality of life as measured by the 'Cantril Ladder'	3 and 12 months post randomization

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: TRYG Foundation; Novavi Outpatient Clinics
• Investigators: Study Director: Janne Tolstrup, Professor, University of Southern Denmark; Study Director: Ulrik Becker, Professor, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: video therapy; e-alcohol therapy; online alcohol treatment; internet-based alcohol treatment; alcohol intervention; proactivity
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Anti-Infective Agents; Physiological Effects of Drugs; Central Nervous System Depressants; Anti-Infective Agents, Local; Ethanol
• Other Study ID Numbers: 63110-2179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No